Promotional Messaging in Health Care Off-Label Promotion, Reprint Usage and Social Media June 2014 Monica Chmielewski, Esq. Special Counsel Foley & Lardner LLP Robin Seifert, Esq. Assistant General Counsel Teleflex Denice Simon, Esq. Assistant General Counsel Takeda Pharmaceuticals
Road Map Necessity of Compliance - Ramifications/Enforcement Key Federal Laws Off-Label Promotion Reprint Usage Social Media 2
Enforcement Landscape Increased focus on federal enforcement activity Hook for enforcement is claims submitted to federal healthcare programs (primarily Medicare, Medicaid) Primary tool has been the federal False Claims Act, which includes whistleblower recoveries Increased (and increasing) data availability Increased physician participation in industry arrangements 3
GlaxoSmithKline (July 2012) Civil claims submitted to federal government and states for Paxil, Wellbutrin and Avandia, plus several other drugs Off-label Promotion and Kickbacks Also included pricing fraud (1994 2003) underpaying Medicaid drug rebates (bundled drugs sold on contingency which included steep discounts ( nominal pricing ) but did not include discounts in reporting best prices underpaid rebates and overcharged PHS entities (340B) Specific criminal allegations (from DOJ Press Release): Paxil (4/1998 8/2003) unlawful promotion for treatment in children; failed to make studies available; sponsored dinner programs, spa programs, paid speaker and doctors for attending programs (costs of meal and spa) Wellbutrin (1/1999 to 12/2003) promoted for treatment of several unapproved uses; paid doctors to speak at and attend meetings; used sales representatives, sham advisory boards, and supposedly independent CME Avandia (2001 2007) failed to include safety data in FDA reports, including post-marketing studies, studies undertaken in Europe in response to regulatory concerns. 4
GlaxoSmithKline (July 2012) Plead guilty and paid $3 billion for civil and criminal liability Largest healthcare settlement ever; largest payment ever by a drug company Criminal: 3 counts 2 misbranding (Paxil and Wellbutrin); 1 failing to report safety data to FDA (Avandia). Criminal fine of $956,814,400 and forfeiture of $43,185,600. Non-monetary compliance commitments and certifications by GSK s U.S. President and board of directors Had to be approved by court Source: U.S. Department of Justice Press Release: GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data (July 2, 2012) 5
AstraZeneca (April 2010) AstraZeneca targeted marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons. Improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. Engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. Recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel. Source: U.S. Dept. of Justice Press Release, Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing (April 27, 2010) 6
Key Federal Laws for Health Care Enforcement 7
Anti-Kickback Statute 42 USC 1320a-7(b) AKS is a criminal prohibition against payments (in any form, whether the payments are direct or indirect) made purposefully to induce or reward the referral or generation of Federal health care program business. ( Illegal Remuneration ) AKS addresses not only the offer or payment of anything of value for patient referrals, but also the offer or payment of anything of value in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or ordering of any item or service reimbursable in whole or in part by a Federal health care program. 8
What might be viewed as remuneration? Consulting fees Other compensation for services Honoraria Gifts Entertainment Food Travel Education Research Charitable Contributions/Royalty or License payments Current or prospective ownership or investment interests Compensation for serving as faculty or speaker for CME Grants Any other payment or transfer of value as defined by DHHS 9
False Claims Act 31 U.S.C. 3729 Includes Medicare and Medicaid (Federal Financial Participation) Civil statute (there is also a criminal version; many states also have similar or even more expansive requirements) Civil Intent: Actual, deliberate ignorance, or reckless disregard Penalties: $5,500 to $11,000/claim; treble damages Includes whistleblower provisions 10
Civil Monetary Penalties Law (CMP) Alternative/Supplement to Civil Action, bases include: False or Fraudulent Claims (same elements and intent standard as FCA) Kickbacks/Stark Violations Cases Initiated by OIG OIG Has to Prove Underlying Facts Six-Year Statute of Limitations DOJ Authorization ALJ Proceeding 11
Off-Label Promotion 12
Off-Label Promotion Focus on Promotion, Not Use Under most circumstances, it is not illegal, or even improper, for a physician to prescribe, or for a patient to use, devices/drugs for off-label purposes. 21 U.S.C. 396 Nothing in the FDCA shall be construed to limit or interfere with the authority of a HCP to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate healthcare practitioner-patient relationship. 13
Primary Theories of Liability for Improper Off- Label Promotion Criminal violations FDCA Anti-Kickback Statute (AKS) Civil Violations False Claims Act Anti-Kickback Statute (resulting in civil false claims or as a basis for a CMP) 14
Criminal Prosecutions Unapproved New Drug 21 U.S.C. 331(d) company distributed labeling that accompanied the drug and prescribed, recommended or suggested the drug for an unapproved use Misbranding 21 U.S.C. 331(a) labeling bears inadequate directions for use or its labeling is false or misleading. See 21 U.S.C. 352(a) 15
What is a label? FDCA Section 201(k) display of written, printed, or graphic matter upon the immediate container of any article. - 21 U.S.C. 321(k) FDCA Section 201(m) labels and other written, printed or graphic material (1) Upon any article or any of its containers or wrappers; or (2) Accompanying such articles. - 21 U.S.C. 321(m) 16
Off-Label Promotion Violations: Price to Be Paid Warning Letters from FDA FCA Settlements/Civil Penalties Criminal Penalties and Potential Exclusion Corporate Integrity Agreement (Part of Civil Settlement) Shareholder Suits Personal Liability for Officers Adverse Event Liability 17
Evidence of Promotional Activities Small market for approved use; large market for offlabel use Increases in off-label use after conferences hosted by manufacturer Business/Strategic Plans Hidden (or overt) company funding for research, articles, speeches Sales Rep Call Notes Promotional activity aimed at off-label prescribing Financial incentives for off-label use 18
Medical Reprints 19
Scientific and Medical Reprints Distributing scientific and medical publications that have content that is on-label is allowable Must be about the approved indication(s) Must be consistent with the approved labeling Can be proactively distributed or in response to a request 20
Off-label Reprints Section 401 of FDAMA - Described certain conditions under which a drug manufacturer could disseminate medical and scientific information that discusses unapproved uses of approved drugs to HCPs and certain entities One of the conditions - The manufacturer would intend to seek FDA approval for the unapproved new use referenced in the disseminated literature FDAMA sunset September 30, 2006 Good Reprint Practices - Guidance of 2009 Consistent with objectives of FDAMA 2014 Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses Not final- comments submitted to FDA May 2, 2014- awaiting FDA action 21
New Draft FDA Guidance (Mar 2014) Covers journal articles, reference texts and clinical practice guidelines Scientific or Medical Journal Articles The publishing organization should have an editorial board that uses experts experts should be independent of the organization review, objectively select, reject, comment full disclosure of conflict of interest 22
New FDA Draft Guidance (Mar 2014) Scientific or Medical Journal Articles Peer-reviewed Unabridged reprint or copy of article Adequate and well-controlled clinical investigations that are scientifically sound Disseminated with approve labeling Disseminated with a comprehensive bibliography (unless already included) Disseminated with a representative publication, when such information exists, that reaches contrary or different conclusions regarding the unapproved use Distributed separately from promotional material 23
New FDA Draft Guidance (Mar 2014) Scientific or Medical Journal Articles must not: Be false or misleading Contain information recommending or suggesting use of the product that makes it dangerous to health when used in that manner Should not: Be a special supplement or publication funded, in whole or in part, by one or more of the manufacturers of the product Be marked, highlighted, summarized, characterized, in writing or orally, to emphasize or promote an unapproved use Be primarily distributed by drug manufacturer Be written, edited, excerpted or published specifically for a drug manufacturer Be edited or significantly influenced by a drug manufacturer or any individual having a financial relationship with mfr Be attached to specific product information (other than PI) 24
New FDA Draft Guidance (Mar 2014) Should be accompanied by a prominently displayed and permanently affixed statement disclosing: The drug in which the manufacturer has an interest That some or all uses of the drug described within have not been approved by FDA Any author with a financial interest or who is receiving compensation from manufacturer Any person known to manufacturer who has provided funding for the study All significant risks or safety concerns associated with the unapproved use of the drug 25
Social Media 26
FDA Position On Social Media FDA views social media promotion in the same context as promotion in any other forms of media Product references must include comprehensive risk information No false or misleading claims No off-label promotion 27
FDA Draft Guidance Affecting Social Media 2009 Draft Guidance on Presenting Risk Information for Drugs and Medical Devices States that FDA applies the same principles of risk disclosure regardless of medium used 2011 Draft Guidance on Unsolicited Requests Touched on social media in the context of responses to unsolicited requested posted on the Internet or in other public forums 2014 Draft Guidance on Postmarketing Submissions of Social Media Addresses procedures for submitting Forms FDA 2253 and 2301 when companies use social media So far, no guidance has been issued to squarely address how promotional materials should be presented on social media so as to satisfy FDA 28
Social Media Warning Letters Merz Pharmaceuticals Untitled Letter July 2013 Use of banner ads without risk information is inadequate note to visit website for full info not sufficient AMARC Enterprises Warning Letter December 2012 Company s act of liking comments on Facebook is akin to endorsing the underlying claim Trinity Sports Group Warning Letter August 2012 Company s Twitter feed contained therapeutic claims requiring corrective action ThermaSolutions Warning Letter May 2012 Video links on 3rd party website linked to company website and company Twitter posts adulterated and misbranded the company s device Warner Chilcott Warning Letter May 2011 No risk information included in 60 second YouTube video made by sales rep in doctor s office Breast Health Imaging Centers Warning Letter January 2011 Off-label claims on mammography in embedded videos and YouTube 29
2014 Draft Guidance FDA acknowledges the existing lack of clarity around social media promotion Provides some insight into FDA s view of the extent of a company s responsibility for communications on social media A firm is responsible for the following promotional content on social media: Promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm Promotion on third party sites under certain circumstances Promotional content generated by an employee or agent who is acting on behalf of the firm Influence appears to be key to responsibility for social media content 30
Open Issues Under 2014 Guidance What constitutes influence? When is someone acting on behalf of a firm? Where is the line between scientific exchange and comments made on behalf of a firm? Comments by Key Opinion Leaders Will the same standards apply to medical device promotion? Guidance focuses on submission of postmarketing reports for drugs and biologics and was prepared by the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research 31
Tips for Managing Social Media Policies/Controls Process for creation, approval, management and archiving of Social Media Campaigns Subject social media promotional materials to the same review as all other materials Monitor social media channels User Generated Content (off-label uses, offensive/ derogatory comments) Product Related Complaints 32
Contact Information Monica Chmielewski, Esq. Special Counsel Foley & Lardner LLP mchmielewski@foley.com Robin Seifert, Esq. Assistant General Counsel Teleflex robin.seifert@teleflex.com Denice Simon, Esq. Assistant General Counsel Takeda Pharmaceuticals denice.simon@takeda.com